A supplier audit checklist is useful only when the questions produce evidence rather than assurances. Most audits fail not because the factory is bad but because the auditor asked closed questions and accepted a yes. The twelve questions below are designed to produce a document, a number or a walk to the line, and each one has an answer that should end the visit.
1. Traceability
Show me the batch record for a recent run of a similar product, including the raw material lot numbers. A good answer takes ten minutes and involves a folder or a system. A bad answer is that the system is being upgraded or that the records are at head office.
2. Water
Show me the water system schematic, the sanitisation schedule and the microbial trend for the last twelve months. A good answer includes sampling points at the use locations. A bad answer is a single outlet result from last month.
3. Cleaning validation
What was the worst-case product pair used to validate cleaning, and what method confirmed it? A good answer names the pair and the analytical method. A bad answer is that the line is always rinsed with water.
4. Deviations
How many deviations were raised last year, and what were the top three? A good answer gives numbers and causes. A bad answer is that there were none.
5. Change control
If a raw material supplier changes, who notifies the customer and how long before the run? A good answer describes a written process, a technical evaluation and a customer notification. A bad answer is that substitutions are only made for equivalent materials, with no definition of equivalent.
6. Capacity and changeover
How many changeovers does the line do per week, and how long does each take? A good answer gives a number and shows the cleaning record. A bad answer is that changeovers are quick. A factory with too many changeovers per week is a factory where cleaning is compressed.
7. Staff and training
Show the training matrix and ask who signs off a new operator before unsupervised work. A good answer names the supervisor and shows the signed record. A bad answer is that everyone is experienced.
8. Testing and laboratories
Which tests are done in-house and which are outsourced, and which laboratory holds the accreditation? A good answer distinguishes the two and names the external lab. A bad answer is that everything is tested.
9. Complaints and returns
What were the top three customer complaints in the last year, and what changed as a result? A good answer describes a corrective action that a brand can see on the line. A bad answer is that there were no complaints.
10. The walk
Walk the line without a prepared route. Look for paperwork at the stations, labelled containers, a calibration sticker with a date, and whether anyone stops working when the auditor appears. A factory that looks the same on an unannounced walk as on a prepared tour is a factory with a system.
11. Commercial profile
Audit visit, one day on site, with a written report within a week. See the production range and the ISO 22716 guide for the certification behind the audit.
